Parkinson DiseaseNCT01798563
Functional Connectivity Parkinson Disease
An observational study of Parkinson Disease, run by University of Colorado, Denver at 1 site in United States.
Trial summary
In this study the investigators are looking at two subtypes of Parkinson Disease (PD); "tremor-dominant" (TD) and postural imbalance and gait disorder (PIGD). This study will use magnet resonance imaging (MRI) to see how the brain reacts while resting and doing a finger-tapping task while on and off PD medication. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with PD according to UK Brain Bank Criteria will be recruited from the UCD Neurology clinic. Controls will be recruited from spouses and from the community
Who may be able to join
- English as their primary language
- Patients with Parkinson disease and healthy controls will be enrolled
- Parkinson patients must be on a dopaminergic medication (levodopa or dopamine agonist) and on a stable dose over the prior month
Who cannot join
- If unable to provide informed consent
- Pregnancy
- Excess of 300lbs
- Claustrophobia
- Metal in body
- Untreated neurological or psychiatric condition, who are delusional or have hallucinations, with cognitive impairment (MOCA<26), with a history of head injury sufficient to cause a concussion, or with significant systemic medical diseases (e.g. heart failure, liver failure, kidney failure, poorly controlled diabetes, etc.)
- Healthy control subjects will be excluded if taking any type of dopaminergic or anti-dopaminergic medication
- Subjects who are unable to demonstrate understanding of the study procedures and risks will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Functional Connectivity of the Motor Network in Two Major Subtypes of Parkinson Disease
In this study the investigators are looking at two subtypes of Parkinson Disease (PD); "tremor-dominant" (TD) and postural imbalance and gait disorder (PIGD). This study will use magnet resonance imaging (MRI) to see how the brain reacts while resting and doing a finger-tapping task while on and off PD medication. This study will look at the differences between the two sub-types of PD and healthy volunteers.
The investigators will test the hypothesis that connectivity at rest within the motor cortex and between the motor cortex and motor-associated regions such as the supplementary motor area and the pre motor cortex will not be as strong in PIGD compared to TD (increased activity and functional connectivity in TD group)
- Conditions
- Parkinson Disease
- Keywords
- Parkinson, Parkinson Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tremor Dominant PD | Volunteers with predominantly tremor-related motor symptoms of PD | |
| Postural Instability & Gait Difficulty PD | Volunteers with primarily walking \& balance-related motor symptoms of PD. | |
| Healthy Controls | Healthy volunteers consisting of people of same age as PD volunteers, w/o a diagnosis of PD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficients between nodes of the motor network at rest and during a tapping motor task.
A measure of the correlation coefficients between nodes of the motor network at rest and during a tapping motor task between the "OFF" and "ON" dopaminergic medication states in the two motor subtype PD patients.
Measured: At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.
Correlation coefficients between nodes of the motor network at rest and during a tapping motor task.
A measure of the correlation coefficients between nodes of the motor network at rest and during a tapping motor task between the "OFF" and "ON" dopaminergic medication states in the two motor subtype PD patients.
Measured: At time of 2nd MRI scan: 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
Second level contrast between Parkinson Disease (PD) and Healthy Controls (HC).
Differences in connectivity as measured by correlation coefficients between nodes of the motor network at rest and during a tapping motor task in PD patients of two motor subtypes and matched healthy controls.
Measured: At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.
Secondary outcomes (5)
Task-related whole-brain activations.
Secondary outcome measures include task-related whole-brain activations as assessed by changes in blood oxygen-dependent (BOLD) contrast during functional magnetic resonance imaging (fMRI) scanning.
Measured: At time of MRI scan, 12 or more hours after their last dose of dopaminergic medication.
Task-related whole-brain activations.
Secondary outcome measures include task-related whole-brain activations as assessed by changes in blood oxygen-dependent (BOLD) contrast during functional magnetic resonance imaging (fMRI) scanning.
Measured: At time of 2nd MRI scan, 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
Connectivity between other motor and non-motor brain regions during the tasks.
Secondary outcome measures include measuring the connectivity between other motor and non-motor brain regions during the tasks.
Measured: At time of MRI scan,12 or more hours after their last dose of dopaminergic medication.
Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments
Secondary outcome measures include a measure of the correlations of brain activity and functional connectivity to structural connectivity measures as well as behavioral and clinical assessments.
Measured: At time of MRI scan. 12 or more hours after their last dose of dopaminergic medication.
Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments
Secondary outcome measures include a measure of the correlations of brain activity and functional connectivity to structural connectivity measures as well as behavioral and clinical assessments.
Measured: At time of 2nd MRI scan. 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startJun 2011
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Berman, MD, MS, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798563
- Sponsor's protocol ID
- 10-1311
- Status last verified
- Oct 2019
- First submitted
- 11 Dec 2012
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Connectivity of the Motor Network in Two Major Subtypes of Parkinson Disease
- ClinicalTrials.gov ID
- NCT01798563
- Acronym / sponsor ID
- 10-1311
- Conditions
- Parkinson Disease
- Keywords
- Parkinson, Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the investigators are looking at two subtypes of Parkinson Disease (PD); "tremor-dominant" (TD) and postural imbalance and gait disorder (PIGD). This study will use magnet resonance imaging (MRI) to see how the brain reacts while resting and doing a finger-tapping task while on and off PD medication. This study will look at the differences between the two sub-types of PD and healthy volunteers.
The investigators will test the hypothesis that connectivity at rest within the motor cortex and between the motor cortex and motor-associated regions such as the supplementary motor area and the pre motor cortex will not be as strong in PIGD compared to TD (increased activity and functional connectivity in TD group)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tremor Dominant PD | – | –Volunteers with predominantly tremor-related motor symptoms of PD |
| Postural Instability & Gait Difficulty PD | – | –Volunteers with primarily walking \& balance-related motor symptoms of PD. |
| Healthy Controls | – | –Healthy volunteers consisting of people of same age as PD volunteers, w/o a diagnosis of PD. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PD according to UK Brain Bank Criteria will be recruited from the UCD Neurology clinic. Controls will be recruited from spouses and from the community
Key inclusion criteria (3 listed)
- English as their primary language
- Patients with Parkinson disease and healthy controls will be enrolled
- Parkinson patients must be on a dopaminergic medication (levodopa or dopamine agonist) and on a stable dose over the prior month
Key exclusion criteria (8 listed)
- If unable to provide informed consent
- Pregnancy
- Excess of 300lbs
- Claustrophobia
- Metal in body
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation coefficients between nodes of the motor network at rest and during a tapping motor task.
Time frame: At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.
A measure of the correlation coefficients between nodes of the motor network at rest and during a tapping motor task between the "OFF" and "ON" dopaminergic medication states in the two motor subtype PD patients.
Correlation coefficients between nodes of the motor network at rest and during a tapping motor task.
Time frame: At time of 2nd MRI scan: 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
A measure of the correlation coefficients between nodes of the motor network at rest and during a tapping motor task between the "OFF" and "ON" dopaminergic medication states in the two motor subtype PD patients.
Second level contrast between Parkinson Disease (PD) and Healthy Controls (HC).
Time frame: At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.
Differences in connectivity as measured by correlation coefficients between nodes of the motor network at rest and during a tapping motor task in PD patients of two motor subtypes and matched healthy controls.
5 secondary outcomes
Task-related whole-brain activations.
Time frame: At time of MRI scan, 12 or more hours after their last dose of dopaminergic medication.
Task-related whole-brain activations.
Time frame: At time of 2nd MRI scan, 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
Connectivity between other motor and non-motor brain regions during the tasks.
Time frame: At time of MRI scan,12 or more hours after their last dose of dopaminergic medication.
Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments
Time frame: At time of MRI scan. 12 or more hours after their last dose of dopaminergic medication.
Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments
Time frame: At time of 2nd MRI scan. 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Berman, MD, MS principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficients between nodes of the motor network at rest and during a tapping motor task. (time frame: At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.